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Suzanne Fiorino, MDIC CfQ Program Manager

MDIC Case for Quality

Open Forum October 8, 2015

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A 501(c)3 - Public-Private Partnership collaborating on Regulatory Science to make patient access to new medical device technologies faster, safer, and more cost-effective

MDIC Highlights

www.MDIC.org

Align Resources

Accelerate Progress

Achieve Results

WORKING COOPERATIVELY to re-engineer pre-competitive

technology innovation

WORKING COOPERATIVELY to re-engineer pre-competitive

technology innovation

REDUCING TIME and resources needed for new

technology development, assessment, and review

REDUCING TIME and resources needed for new

technology development, assessment, and review

HELPING PATIENTS gain access to new medical

technologies sooner

HELPING PATIENTS gain access to new medical

technologies sooner

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The FDA Case for Quality – History

• Background:−Observations of repetitive quality issues among device

manufacturers

−Stagnant data regarding these quality issues

• Response:−Engaged McKinsey to analyze device quality issues

−Reported on these findings in the 2011 “Understanding Barriers to Quality” white paper

−Developed a plan to address these findings, aka the Case for Quality

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The Case for Quality – Intent

• The Case for Quality initiative is intended to drive through the barriers to medical device quality identified in the white paper.

• Elevate the device sector focus from baseline regulatory compliance to a sustained state of enhanced medical quality.

• Achieve this by creating continuous engagement with a broad set of stakeholders in the device product quality arena.

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MDIC Case for QualityBroad Agency Agreement (BAA)

Goal: Develop a better understanding of what changes are necessary to catalyze industry movement towards improved device quality. 

Strategy: Conduct research through Quality Engagement Forums of medical device industry stakeholders and summarize the findings from those interactions in a comprehensive Change Action Plan.

Objectives:1.Conduct research on Quality Maturity Models, 2.Create a venue for Quality Engagement Forums, 3.Create a list of key topics to be used to generate discussion and interaction during these sessions, 4.Develop a Change Action Plan summarizing the results.

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MDIC Case for Quality 2015* Schedule

Open/Large Forums

Forums

SC

MDICxJune 24th

October 8 San Diego, CA

March 24th

Washington, DCMay 20th

Washington, DCSeptember 8th

Washington, DCDec 8th

Working Groups

Current

Updates Updates Updates

SC Reviews/ Approves New Working Groups

Steering Committee Meetings Regular Forum Meetings Periodic Open Forum Meetings Working Groups meet and make progress between Forum Meetings

* First Forum date in 2016 will be March 8th

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MDIC Case for Quality Program

Program Manager Steering Committee

Board Champion: Aran MareeProgram Manager: Suzanne FiorinoFDA: Steve Solomon, Jan WelchMembers: Sarah Deegan, Joe Sapiente (Industry SC head), Joanna Engelke, Beth Staub, Steve Binion [Tech Adv - Garth Conrad & Francisco Vicenty]

MDIC Staff

President – CEO – Bill MurraySupport Staff

Working Groups

WG

Competencies

WG

Quality Maturity Models

Analytics(Early Development

Work)

WG

Future - TBD

WG

Measures

WG

Future - TBD

Chair: Kristin McNamaraMarla Phillips

Chair: Joe SapientePat Baird

Chair:Bill Murray;actingGeorge Serafin

Chair:Garth Conrad Joanna Engelke

Chair:TBD

Chair:TBD

Quality Forum

Industry Representatives, FDA, Customer[s], Other Stakeholders & Associations